Clinical Regulatory Writing & Publication
Saliegral started by core medical writing company before expanding into other solutions and we pride ourselves by 100% retention rate of our client in this space. One of our founder members has worked with global CROs and Pharma for over 17 years and her passion and experience reflects on every document we produce for our client.
We are flexible enough to work on client templates including or you can choose to pick our templates and tools for your medical writing needs. We team has experienced across the therapeutic area including but not limited to, oncology, hematology, central nervous system, urology, cardiovascular, infectious diseases (including COVID-19), general medicine, respiratory, dermatology, gynecology, orthopedics, vaccines, ophthalmology, endocrinology, medical device and diagnostics, radio pharmaceutical, nutritional products, medical aesthetics, dental.
- Clinical Protocol/Clinical Investigation Plan
- Case Report Forms
- Informed Consent Form/Ascent Forms
- Investigator’s Brochure (IB)
- Clinical Study Reports (CSR)
- Clinical Evaluation Reports (CER)
- Clinical Trials Publication Manuscripts and Posters
- New Drug Application (NDA)
- Investigation Medicinal Product Dossier (IMPD)
- Orphan Drug Designation (ODD) application
- eCTD Modules 2.5 and 2.7
- Preclinical study reports
- Abbreviated Clinical Study Reports or Synopsis
- Summary of Product Characteristics
- Protocol Slide Kits & Investigator Training Material
- Patient reported outcome document – patient diaries etc.
- Lay Person Summaries
- Clinical Trial Disclosures
- Protocol summary registration
- Clinical Trials Results Reporting
we also offer
Standalone Medical Editing, Quality Control Review across clinical regulatory suites of documents. In addition, we provide document redaction solution, to support all your data transparency and anonymization needs.
We have our own proprietary editing, and authoring tools that we deploy across our medical writing documents.
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